Skip to main content
Clinical Trials/ACTRN12611000972921
ACTRN12611000972921
Completed
Phase 2

An Investigator-Initiated Phase 2, Single Centre, Double-Blind, Randomised, Controlled Trial of the Effect of Adalimumab Upon Endothelial Function in Patients with Early and Established Anti-CCP Antibody Positive Rheumatoid Arthritis.

A/Prof Stephen Oakley0 sites60 target enrollmentSeptember 12, 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
A/Prof Stephen Oakley
Enrollment
60
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 12, 2011
End Date
January 29, 2016
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
A/Prof Stephen Oakley

Eligibility Criteria

Inclusion Criteria

  • Group 1: Early Rheumatoid Arthritis: Anti\-CCP (ACPA) positive rheumatoid arthritis of less than 1 year duration by onset of symptoms, age over 18 years, CRP \> 15 mg/L or DAS28\-CRP\>3\.20 within 1 week of enrolment.
  • Group 2: Established Rheumatoid Arthritis: Anti\-CCP (ACPA) positive rheumatoid arthritis of greater than 1 year duration by onset of symptoms, age over 18 years, CRP\>15 mg/L or DAS28\-CRP\>3\.20 within one month of enrolment

Exclusion Criteria

  • 1\. Disease Remission (ACR / EULAR 2010 Criteria) or CRP\<15 mg/L
  • 2\. Anti\-CCP antibody test negative
  • 3\. Serious malignancy within the last 5 years
  • 4\. Demyelinating Disease
  • 5\. Evidence of previous untreated TB infection

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination with DaratUMumab followed by Maintenance with Daratumumab in the Frontline Setting of Primary Plasma CEll LEukemIA: A Trial of the Greek Myeloma Study GroupPrimary plasma cell leukemiaMedDRA version: 20.0Level: LLTClassification code 10035223Term: Plasma cell leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2021-001990-22-GRHellenic Society of Haematology (HSH)43
Completed
Not Applicable
An investigator-initiated, multicenter, phase II study to determine the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory CD30-positive cutaneous T-Cell lymphomaCohort 1: Subjects with CD30+ mycosis fungoides or pcALCL Cohort 2: Subjects with other (non-Cohort 1) CD30+ cutaneous T-Cell lymphomas
JPRN-UMIN000034205Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences15
Completed
Phase 2
A multicenter, investigator-initiated phase II clinical trial involving administration of a cross-linked gelatin hydrogel containing recombinant human basic fibroblast growth factor (rh-bFGF) to prevent the collapse of the femoral headOsteonecrosis of the femoral head
JPRN-UMIN000020340Haruhiko Akiyama, Gifu University Hospital64
Active, not recruiting
Phase 1
A pilot study of enalapril in venous malformationsVenous malformationTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
CTIS2023-510076-31-00Oslo University Hospital HF1
Active, not recruiting
Not Applicable
A phase II, open, single centre, exploratory study to evaluate the safety and immunogenicity of one booster dose of a GSK Biologicals’ Hepatitis B vaccine Engerix™-B or a of GSK Biologicals’ HIV candidate vaccine (732461), administered intramuscularly, in conjunction with the administration of a single oral dose of chloroquine in healthy adults. - EARLY-CLINRES-004Immunisation against Hepatitis B and HIV in healthy adults aged between 18-52 years old, inclusive.
EUCTR2009-012223-29-BEGlaxoSmithKline Biologicals